Tumor Hyperinsulinism (Tumor HI)Phase 3Tumor HINCT06881992
A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism
A Phase 3 study testing Ersodetug in people with Tumor Hyperinsulinism (Tumor HI), run by Rezolute at 13 sites in 5 countries.
Trial summary
The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug as add-on to standard of care (SOC) therapy for treatment of hypoglycemia in patients with Tumor Hyperinsulinism (Tumor HI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor Hyperinsulinism (Tumor HI)
- What is being tested?
- Ersodetug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 16 Apr 2025to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The eligibility criteria of all participants must be evaluated by a multidisciplinary team led by the PI, which must include an oncologist
- Male or female participants of ≥18 years of age who provide written informed consent.
- Clinical diagnosis of neuroendocrine tumor (NET) (ICT or NICT) with biochemical evidence of tumor hyperinsulinism (hypoglycemia with inappropriately elevated insulin or insulin-like growth factor (IGF)/variant suppression) confirmed via laboratory assessment who have failed to achieve adequate control of hypoglycemia with usual SOC anti-hypoglycemic therapies, per investigator judgement.
- Currently requiring IV glucose infusion and/or parenteral nutrition for ≥7 days for the management of refractory hypoglycemia (prior to administration of the 1st dose of ersodetug).
Who cannot join
- Evidence of active infection including human immunodeficiency virus, hepatitis B, or hepatitis C (excluding immunization patterns).
- Treatment with an investigational drug or device within 30 days or 5 half-lives of the investigational drug (whichever is longer), however, if the treating physician and Medical Monitor consider no significant risk of drug-drug interaction and potential benefit outweighs the risk then the participant may be allowed to participate. Participation in registries and purely diagnostic studies is allowed
- Any out-of-range laboratory value at screening (other than glucose) that is assessed as clinically significant by the investigator. Laboratory or radiographic abnormalities that are considered related to the underlying disease (tumor) or associated therapies and do not pose additional safety risk for study participation per investigator and Medical Monitor may be allowed.
- Known allergy or sensitivity to ersodetug or any component of the drug.
- Any organ condition, concomitant disease (e.g., psychiatric illness, severe alcoholism, or drug abuse, cardiac, hepatic, or kidney disease), or other abnormality that itself, or the treatment of which in the opinion of the investigator and/or Sponsor's Medical Monitor would pose an unacceptable risk to the participant in the study.
- Estimated life expectancy (additional lifespan) due to underlying disease (tumor) is <8 weeks.
Trial locations and contacts
13 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 5 countries
United States8 sites, 8 recruiting
- Recruiting
Investigative Site
Bethesda, Maryland, 20892
- Recruiting
Investigative Site
Boston, Massachusetts, 02114
- Recruiting
Investigative Site
Canton, Ohio, 44718
- Recruiting
Investigative Site
Chicago, Illinois, 60637
- Recruiting
Investigative Site
Houston, Texas, 77030
- Recruiting
Investigative Site
New York, New York, 10021
- Recruiting
Investigative Site
Portland, Oregon, 97239
- Recruiting
Investigative Site
Rochester, Minnesota, 55905
United Kingdom2 sites, 2 recruiting
- Recruiting
Investigative Site
Saint Johns Wood, London, NW3 2QG
- Recruiting
Investigative Site
Withington, Manchester, M20 4BX
France1 site, 1 recruiting
- Recruiting
Investigative Site
Clichy, Île-de-France Region, 92110
Netherlands1 site, 1 recruiting
- Recruiting
Investigative Site
Rotterdam, South Holland, 3015
Switzerland1 site, 1 recruiting
- Recruiting
Investigative Site
Basel, Canton Basel-Stadt, CH-4001
About this study
Official title: A Phase 3, Single-Arm, Open-label, Pivotal Study to Evaluate the Efficacy and Safety of Ersodetug Compared to Baseline in Patients With Inadequately Controlled Hypoglycemia Due to Tumor Hyperinsulinism (Tumor HI)
The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug as add-on to standard of care (SOC) therapy for treatment of hypoglycemia in patients with Tumor Hyperinsulinism (Tumor HI).
Read the detailed description
This study will include participants who are suffering from low blood sugar related symptoms (hypoglycemia) due to over-production of hormones (e.g. insulin or similar substances) by certain non-removable tumors that cannot be treated satisfactorily with available treatment. Every study participant will receive ersodetug doses weekly for 8 weeks alongside their usual treatments for hypoglycemia at a dose of 9 mg/kg.
The study is divided into 3 periods: Screening (up to 4 weeks), Treatment (8 weeks) and either End of Study Follow-up (approximately up to 20 weeks after the last dose) or optional Open Label Extension (OLE) phase (up to 3 years).
This study is being conducted at approximately 10-15 study sites in approximately 5 countries. The study will enroll approximately 16 participants, all with a diagnosis of tumor HI (insulin- or IGF producing tumors).
- Conditions
- Tumor Hyperinsulinism (Tumor HI)
- Being tested
- Ersodetug
- Keywords
- Doege-Potter Syndrome, Ectopic insulinoma, Extra-pancreatic insulinoma, Fibrosarcoma, HCC, Hyperinsulinemia, Hypoglycemia, Hypoglycemia due to fibrosarcoma, Hypoglycemia due to HCC, Hypoglycemia due to liposarcoma, Hypoglycemia due to tumor/cancer, IGF 2 Insulinoma, IGF 2 mediated non islet cell tumor hypoglycemia, IGF-2 mediated hypoglycemia, IGF-2, Big IGF-2, IGF-oma, IGF-2-oma, Big IGF-2-oma, Insulinoma, Islet cell tumor (ICT), Liposarcoma, Neuroendocrine tumor (NET)
- Medical subject headings
- Fibrosarcoma, Hyperinsulinism, Hypoglycemia, Neoplasms, Insulinoma, Adenoma, Islet Cell, Liposarcoma, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErsodetugDrug
Ersodetug (9 mg/kg) + SOC
| Study group | Role | What they receive |
|---|---|---|
| Participants with a diagnosis of Tumor HI (insulin- or IGF-producing tumors) | Other | Not described Receives: Drug: Ersodetug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with clinically meaningful reduction in IV glucose infusion rate from baseline.
Measured: 8 weeks
Secondary outcomes (3)
Change from baseline in average daily IV glucose/dextrose infusion rate (GIR).
Measured: 8 weeks
Change from baseline in average daily total IV glucose delivery (g)
Measured: 8 weeks
Time to complete weaning off IV glucose administration after initiating ersodetug.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start16 Apr 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor Hyperinsulinism (Tumor HI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rezolute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881992
- Sponsor's protocol ID
- RZ358-302
- Acronym
- Tumor HI
- Status last verified
- Sep 2026
- First submitted
- 10 Mar 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Single-Arm, Open-label, Pivotal Study to Evaluate the Efficacy and Safety of Ersodetug Compared to Baseline in Patients With Inadequately Controlled Hypoglycemia Due to Tumor Hyperinsulinism (Tumor HI)
- ClinicalTrials.gov ID
- NCT06881992
- Acronym / sponsor ID
- Tumor HI / RZ358-302
- Conditions
- Tumor Hyperinsulinism (Tumor HI)
- Keywords
- Doege-Potter Syndrome, Ectopic insulinoma, Extra-pancreatic insulinoma, Fibrosarcoma, HCC, Hyperinsulinemia, Hypoglycemia, Hypoglycemia due to fibrosarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- RezoluteUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug as add-on to standard of care (SOC) therapy for treatment of hypoglycemia in patients with Tumor Hyperinsulinism (Tumor HI).
Detailed description
This study will include participants who are suffering from low blood sugar related symptoms (hypoglycemia) due to over-production of hormones (e.g. insulin or similar substances) by certain non-removable tumors that cannot be treated satisfactorily with available treatment. Every study participant will receive ersodetug doses weekly for 8 weeks alongside their usual treatments for hypoglycemia at a dose of 9 mg/kg.
The study is divided into 3 periods: Screening (up to 4 weeks), Treatment (8 weeks) and either End of Study Follow-up (approximately up to 20 weeks after the last dose) or optional Open Label Extension (OLE) phase (up to 3 years).
This study is being conducted at approximately 10-15 study sites in approximately 5 countries. The study will enroll approximately 16 participants, all with a diagnosis of tumor HI (insulin- or IGF producing tumors).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with a diagnosis of Tumor HI (insulin- or IGF-producing tumors) | Other | Drug: Ersodetug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The eligibility criteria of all participants must be evaluated by a multidisciplinary team led by the PI, which must include an oncologist
- Male or female participants of ≥18 years of age who provide written informed consent.
- Clinical diagnosis of neuroendocrine tumor (NET) (ICT or NICT) with biochemical evidence of tumor hyperinsulinism (hypoglycemia with inappropriately elevated insulin or insulin-like growth factor (IGF)/variant suppression) confirmed via laboratory assessment who have failed to achieve adequate control of hypoglycemia with usual SOC anti-hypoglycemic therapies, per investigator judgement.
- Currently requiring IV glucose infusion and/or parenteral nutrition for ≥7 days for the management of refractory hypoglycemia (prior to administration of the 1st dose of ersodetug).
Key exclusion criteria (6 listed)
- Evidence of active infection including human immunodeficiency virus, hepatitis B, or hepatitis C (excluding immunization patterns).
- Treatment with an investigational drug or device within 30 days or 5 half-lives of the investigational drug (whichever is longer), however, if the treating physician and Medical Monitor consider no significant risk of drug-drug interaction and potential benefit outweighs the risk then the participant may be allowed to participate. Participation in registries and purely diagnostic studies is allowed
- Any out-of-range laboratory value at screening (other than glucose) that is assessed as clinically significant by the investigator. Laboratory or radiographic abnormalities that are considered related to the underlying disease (tumor) or associated therapies and do not pose additional safety risk for study participation per investigator and Medical Monitor may be allowed.
- Known allergy or sensitivity to ersodetug or any component of the drug.
- Any organ condition, concomitant disease (e.g., psychiatric illness, severe alcoholism, or drug abuse, cardiac, hepatic, or kidney disease), or other abnormality that itself, or the treatment of which in the opinion of the investigator and/or Sponsor's Medical Monitor would pose an unacceptable risk to the participant in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErsodetugErsodetug (9 mg/kg) + SOC | Drug | Participants with a diagnosis of Tumor HI (insulin- or IGF-producing tumors) |
Primary outcome
Proportion of participants with clinically meaningful reduction in IV glucose infusion rate from baseline.
Time frame: 8 weeks
3 secondary outcomes
Change from baseline in average daily IV glucose/dextrose infusion rate (GIR).
Time frame: 8 weeks
Change from baseline in average daily total IV glucose delivery (g)
Time frame: 8 weeks
Time to complete weaning off IV glucose administration after initiating ersodetug.
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ersodetug in people with Tumor Hyperinsulinism (Tumor HI), run by Rezolute at 13 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, United Kingdom, France, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rezolute Clinical Trial (650-206-4507, clinicaltrials@rezolutebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with clinically meaningful reduction in IV glucose infusion rate from baseline. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.